The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
Evaluation of patients for ST segment changes.
Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
Clinical and epidemiological research studies.
Evaluation of patients with pacemakers
Reporting of time and frequency domain heart rate variability
Reporting of QT Interval

Device Description

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.

Attribute	DXP1000	Model #1005
Storage capacity	Up to 48 hours	24 hours
Memory type	Flash (non-volatile)	Flash (non-volatile)
Memory portability	Non-removable	Non-removable
On-board ECG analysis	No	Yes
Liquid Crystal Display (LCD)	Yes	No
Data transfer method	USB port	Bi-directional parallel I/O
Pacemaker detection & reporting	Yes	Yes
Belt clip	Yes	No
Battery	One AA	Four AA
Size	11 x 7 x 2cm	15 x 6 x 2 cm
Weight	135g	140 g

AI/ML Overview

The provided text describes a 510(k) submission for the DXP1000 Holter Recorder, focusing on modifications and demonstrating substantial equivalence to a predicate device (Biosensor Model #1005).

Here's an analysis of the acceptance criteria and the study information available in the provided text:

Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Predicate: Model #1005)	Reported Device Performance (DXP1000)
Pacemaker detection	Yes	Yes
Pacemaker reporting	Yes	Yes
Storage capacity	24 hours	Up to 48 hours
Memory type	Flash (non-volatile)	Flash (non-volatile)
Memory portability	Non-removable	Non-removable
On-board ECG analysis	Yes	No
Liquid Crystal Display (LCD)	No	Yes
Data transfer method	Bi-directional parallel I/O	USB port
Belt clip	No	Yes
Battery	Four AA	One AA
Size	15 x 6 x 2 cm	11 x 7 x 2 cm
Weight	140 g	135 g

Note: The primary focus of the modification and validation was the "pacemaker detection logic." The other attributes in the table represent direct comparisons of specifications between the modified device and the predicate.

Study Information

The provided text offers very limited details about the actual study conducted to validate the modified pacemaker detection logic. Here's what can be inferred:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states that "ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956)." This indicates the DXP1000 is a recorder only, and any AI/analysis component would be in separate software. Therefore, there's no mention of human readers or AI assistance effect sizes for this specific device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone validation of the "pacemaker detection logic" was performed. The text states, "the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." This validation pertains to the device's inherent capability to detect pacemakers.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given it's pacemaker detection, the ground truth would likely involve expert review of ECG traces or potentially verified pacemaker presence/absence records coupled with ECG data where pacemaker spikes are either known to be present or absent.
The sample size for the training set:
- Not specified. The document focuses on validation of a modified logic, implying existing development, but does not detail a training set for a new AI model.
How the ground truth for the training set was established:
- Not specified. Assuming any "training" (if applicable, perhaps during the initial development of the pacemaker detection logic in the predicate device or an earlier iteration) involved expert review of annotated ECG waveforms.

In summary: The provided text is a 510(k) summary for a modified Holter recorder. It focuses on physical changes to the device and a slight modification to the pacemaker detection logic. While it states this logic was "validated," it provides minimal details regarding the methodology, sample sizes, ground truth establishment, or expert involvement in that validation study. The document explicitly differentiates this recorder from the ECG analysis software, which would be subject to separate review and where more detailed performance studies for algorithms might be expected.

Summary

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NOV 2 4 1999

K9936/8

Section 2: 510(k) SUMMARY

. Substantially Equivalent (SE) To:
Biosensor Model #1005 510(k) # K950944

Modification Background

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.

Attribute	DXP1000	Model #1005
Storage capacity	Up to 48 hours	24 hours
Memory type	Flash (non-volatile)	Flash (non-volatile)
Memory portability	Non-removable	Non-removable
On-board ECG analysis	No	Yes
Liquid Crystal Display (LCD)	Yes	No
Data transfer method	USB port	Bi-directional parallel I/O
Pacemaker detection & reporting	Yes	Yes
Belt clip	Yes	No
Battery	One AA	Four AA
Size	11 x 7 x 2cm	15 x 6 x 2 cm
Weight	135g	140 g

Comparison To The SE Device: .

NOTE: Together with this Special 510(k), another Special 510(k) has been filed on a similar device (DigiTrakPlus) utilizing alternative hardware which is slightly smaller in size. Both devices incorporate the same fundamental scientific technology, and indeed a substantially identical electro-mechanical design. For clarity, the submitter wishes to note to the reviewer that these two devices are essentially the same other than the size and weight characteristics noted.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

Mr. David Norberg Regulatory Affairs Representative Braemar, Inc. 11481 Rupp Drive 55337 Burnsville, Minnesota

Re: K993618 DXP1000 Holter Recorder Requlatory Class: II (two) Product Code: MWJ October 25, 1999 Dated: Received: October 26, 1999

Dear Mr. Norberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Norberg

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DXP1000 Holter Recorder

510(k) Number: K99 3618

Indications for Use:

(No change from predicate device)

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

1. Evaluation of patients for ST segment changes.
1. Evaluation of a patient's response after resuming occupational activities (e.g.,

after M.I. or cardiac surgery.)

1. Clinical and epidemiological research studies.
1. Evaluation of patients with pacemakers
1. Reporting of time and frequency domain heart rate variability
1. Reporting of QT Interval

V. Darlene Rich

(Division Sign-Off Division of Cardiovascular, Respira and Neurological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).